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Brief Title: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality
Official Title: Adjuvant Melatonin for Prevention of Lung Cancer Recurrence and Mortality: A Randomized Placebo Controlled Clinical Trial
Study ID: NCT00668707
Brief Summary: There is evidence to support the use of melatonin, a natural health product, as an additional treatment aid for cancer patients. This study is designed to see if the daily ingestion of 20 milligrams of melatonin for one year can lower the incidence of developing lung cancer recurrence and/or death. Only patients with a diagnosis of non small cell lung cancer who are eligible for surgical resection can participate in the trial. The study will also be assessing for changes in quality of life, pain, fatigue, anxiety, sleep, and depression amongst the participants.
Detailed Description: The trial employs a two-armed parallel placebo controlled trial design whereby patients with a diagnosis of non small cell lung cancer are randomized to receive either 20 mg of melatonin nightly or an identically matched placebo. All patients will be followed for two years with primary outcomes assessed at a two year time point and secondary outcomes evaluated throughout the course of the trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kelowna General Hospital, Kelowna, British Columbia, Canada
Fraser Health, Surrey, British Columbia, Canada
QEII Health Sciences Centre/Capital Health, Halifax, Nova Scotia, Canada
St. Joseph's/ McMaster University, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Ottawa General Hospital, Ottawa, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec, Quebec, , Canada
Name: Dugald MR Seely, ND, MSc
Affiliation: The Canadian College of Naturopathic Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Andrew JE Seely, MD
Affiliation: The Ottawa Hospital
Role: PRINCIPAL_INVESTIGATOR